This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.) (NCT00586313), a na na study. The primary outcome is Median Total Specimen Length.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00586313 |
| Phase | NA |
| Condition | Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 21 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Indiana University |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 21 people. The primary outcome description groups results by indication for liver biopsy: suspected NAFLD, intrahepatic cholestasis, exclusion of cirrhosis, and increased liver function tests of uncertain cause. The record does not report the number of participants in each indication group or provide further eligibility details.
Intervention
Participants underwent EUS-guided Tru-Cut liver biopsy. The study description explains that EUS uses a flexible camera passed through the mouth into the stomach, with a needle used to obtain liver tissue through the stomach lining.
Comparator
There was no separate control group. The study is recorded as a single-group study, and allocation is listed as NA. Consequently, the results do not provide a like-for-like comparison with another biopsy technique or with no biopsy.
Primary question
The primary outcome was median total specimen length, measured in millimetres, with a full range. The registry record describes this outcome by biopsy indication and for the total group. The clinical question is whether this procedure obtained liver tissue and what specimen lengths were recorded; the actual lengths are not reported in the registry record.
The study also lists the number of procedural complications as a secondary outcome. The registry record reports adverse-event counts, but does not provide a result for that named secondary outcome. The study description gives the clinical rationale for obtaining liver tissue: biopsy can allow examination for inflammation or scar tissue. That rationale does not establish how often those findings occurred in this study, nor does it establish the diagnostic performance of the procedure. Those results are not reported in the registry record.
3. Trial Design
This was a completed, single-group clinical study with an enrollment of 21. It evaluated EUS-guided Tru-Cut biopsy of the liver. The registry lists the intervention as both a device and a procedure, and describes one arm, Tru-Cut biopsy for liver. No comparator arm is reported. Allocation is listed as NA, and the study model is single group; it is therefore not a randomized comparison.
Masking is recorded as none. The registry lists the phase as NA and the study kind as other. The study began in 2007-01 and its primary completion was 2008-07. These dates describe the registry record, but do not establish the timing of every participant’s procedure or outcome assessment. The primary outcome timeframe is recorded as 24 months; the record does not explain the timing rules or assessment schedule in more detail.
The primary outcome is median total specimen length, in millimetres, reported with a full range. Its description says results were grouped by indication for liver biopsy and for the total. The indications named are suspected NAFLD, intrahepatic cholestasis, exclusion of cirrhosis, and increased liver function tests of uncertain cause. The registry does not give the number of participants in each group or the actual specimen-length results.
The secondary outcome is the number of procedural complications. The record also contains adverse-event counts, but does not report a specific result for the named secondary outcome. A sample-size justification, recruitment target rationale, detailed statistical analysis plan, interim analysis plan, and allocation procedure are not reported in the registry record. No separate treatment-effect comparison can be drawn from a one-group design.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | EUS Tru-cut Biopsy |
|---|---|
| STARTED | 21 |
| COMPLETED | 19 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | EUS Tru-cut Biopsy |
|---|---|
| Lack of Efficacy | 2 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: 13 females
| Characteristic | Unit | Participants Undergoing the Tru-Cut Biopsy |
|---|---|---|
| Participants analysed | 21 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 21 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 13 |
| Sex: Female, Male: Male | Participants | 8 |
| Region of Enrollment: United States | participants | 21 |
6. Primary Endpoint
The registry lists the primary outcome as Median Total Specimen Length, measured over 24 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | mm |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is median total specimen length, measured in millimetres, with a full range. The registry describes the measure for the total group and separately by biopsy indication. It names suspected NAFLD, intrahepatic cholestasis, exclusion of cirrhosis, and increased liver function tests of uncertain cause as the indications.
In general, specimen length is a procedural measure: it describes the amount of tissue obtained, rather than a clinical outcome such as symptoms or long-term health. It can be relevant when evaluating whether a biopsy procedure yields tissue for examination. However, length alone does not establish whether a specimen is adequate for diagnosis, whether it is representative of the liver, or whether a diagnosis was correctly made. The registry record does not report an adequacy threshold, histological findings, diagnostic accuracy, or a relationship between specimen length and clinical outcomes.
The actual median lengths and full ranges are not reported in the registry record. Nor does the record explain how lengths were measured, how multiple tissue pieces were handled, or how missing measurements were treated. As a result, the endpoint’s definition is available, but its observed values and practical interpretation cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a 21-participant, single-group study of EUS-guided Tru-Cut liver biopsy. It identifies median total specimen length as the primary outcome and the number of procedural complications as a secondary outcome. However, it does not report the observed specimen lengths or a result for the named secondary outcome. The record therefore establishes what the study set out to measure, but does not provide the primary result needed to describe the tissue obtained.
Without a reported median or full range, it is not possible to characterize the distribution of specimen lengths, compare lengths across the listed biopsy indications, or judge how much the results varied among participants. The registry also does not state a benchmark for interpreting specimen length, such as an adequacy criterion. Even if those measurements were available, specimen length alone would not establish the quality or diagnostic usefulness of the tissue.
The study has no separate comparator group. Its data therefore cannot estimate a comparative difference between EUS-guided Tru-Cut biopsy and another biopsy method, nor distinguish the procedure’s outcomes from what would have occurred under an alternative approach. The absence of a control group is a design feature, not evidence that the procedure is better or worse than another method.
The posted adverse-event counts list 21 people at risk for serious events and 0 with a serious event; for other events, 21 were at risk and 0 were affected. These counts describe the recorded safety data, not a comparative safety effect. They do not establish that no complications of any kind occurred, because the named secondary outcome result and further event details are not reported in the registry record. Deaths are listed as null, so a death count is not available in the record.
Precision also cannot be evaluated for the primary outcome because no estimate or uncertainty interval is reported. The registry record does not provide an analysis result, a statistical test, or an estimate of variability beyond specifying that the planned dispersion measure was the full range. Thus, no claim about the magnitude or precision of specimen length results can be supported. The record’s missing outcome values should not be read as zero values or as proof of no effect.
Overall, the registry supports a description of the study design, outcome definitions, enrollment, and posted adverse-event counts. It does not support a conclusion about the primary endpoint’s observed distribution, diagnostic performance, or comparative effectiveness. Any planning illustrations based on observed effects should be interpreted as hypothetical design calculations, not as evidence of observed power or as a substitute for the missing outcome estimates. In this case, an observed primary effect is not reported in the registry record.
9. Statistical Methods Explained
The study is recorded as a single-group design. This means the registry describes one group receiving EUS-guided Tru-Cut liver biopsy, rather than separate groups assigned to different procedures. Allocation is listed as NA, and the record explicitly does not describe a randomized comparison. In general, a randomized comparison can help separate differences associated with assigned treatments from other differences between participants. That purpose cannot be served by a one-group study without a comparator.
What does the median describe?
In general, the median is the middle value after observations are ordered. It is a measure of the centre of a distribution and is less influenced by unusually high or low values than the arithmetic mean. The registry identifies median total specimen length as the primary measure, but the median itself is not reported in the registry record. The record also specifies a full range. In general, a range reports the smallest and largest observations, conveying the span of measured values but not how observations are distributed between its endpoints. The range values are not reported in the registry record either.
Why group results by indication?
The outcome description distinguishes suspected NAFLD, intrahepatic cholestasis, exclusion of cirrhosis, increased liver function tests of uncertain cause, and the total group. In general, reporting by indication can show whether a procedural measure differs across clinical reasons for biopsy. Such subgroup descriptions require careful interpretation: groups can be small, and their results may be less precise than an overall result. The record does not report group sizes or subgroup estimates, so neither the size nor the precision of any subgroup result can be evaluated.
What can be learned from a confidence interval?
In general, a confidence interval expresses uncertainty around an estimate under a specified statistical method. It helps readers assess which values are compatible with the data and method, rather than treating one point estimate as exact. No confidence interval for specimen length or another primary outcome estimate is reported in the registry record. The amount of uncertainty around the primary endpoint therefore cannot be assessed from the posted results.
What do planning illustrations mean?
In general, sample-size planning calculations ask how many participants might be needed to detect a chosen effect under stated assumptions. The planning assumptions associated with the registry describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of an observed effect. These are planning assumptions, not a description of this study’s single-group design. Any resulting sample-size figures are planning illustrations, not observed power. Because the primary observed effect is not reported in the registry record, such calculations cannot be evaluated against an available primary result. They do not show the probability that this completed study detected an effect.
In general, a normal approximation uses a normal distribution to approximate the sampling distribution of an estimate or test statistic. Whether that approximation is suitable depends on the outcome, design, and data. The registry does not report the analysis method used for the specimen-length endpoint, so it is not possible to determine whether a normal approximation, another method, or no formal test was used for the primary outcome.
How should event counts be interpreted?
In general, event counts describe how many events were observed in the group being monitored. Counts alone do not give a comparative effect when no control group is present. They also need clear definitions, observation periods, and rules for classifying events to support interpretation. The registry records 21 people at risk for serious adverse events and 0 affected, and 21 at risk for other adverse events and 0 affected. The specific event definitions and further details are not reported in the registry record. A zero count in these posted data is not proof that the underlying risk is zero.
What analysis details are available?
The registry record does not report an analysis result for the primary endpoint, and no analyses are listed. A detailed statistical plan, adjustment methods, and the handling of missing measurements are not reported in the registry record. Without those details, readers cannot determine whether analyses were prespecified, whether any adjustments were made, or how the reported outcome definitions were applied to collected data. The absence of listed analyses does not establish that no analysis took place; it means that an analysis is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry names a primary outcome, median total specimen length, and a secondary outcome, the number of procedural complications. The primary outcome description also specifies reporting by several biopsy indications and for the total. Multiple outcomes or subgroup comparisons can raise multiplicity concerns: in general, the more hypotheses examined, the greater the chance that at least one result appears notable by chance if each is tested separately. The registry record does not report whether formal tests were performed, whether any adjustment for multiple comparisons was planned, or whether the indication-specific summaries were inferential analyses rather than descriptive reporting.
Missing-data handling is not reported in the registry record. It does not state whether all enrolled participants contributed a specimen-length measurement, how incomplete or unusable samples were treated, or how any missing safety information was handled. Enrollment of 21 does not by itself establish that all 21 had complete data for every outcome.
The analysis population is also not reported in the registry record. There is no description of whether the primary analysis included everyone enrolled, only those who underwent the procedure, or another defined group. The record gives no participant flow or exclusions from analysis. These details matter because the analyzed participants and the rules for handling incomplete observations affect how outcome summaries should be understood.
There is no analysis count listed, and a detailed statistical analysis plan is not reported in the registry record. Consequently, prespecification, multiplicity control, missing-data assumptions, and the analysis population cannot be verified from the posted record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| EUS Tru-cut Biopsy | 0 | 21 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| EUS Tru-cut Biopsy | 0 of 21 |
The posted adverse-event data list 21 people at risk for serious adverse events, with 0 affected. For other adverse events, the record also lists 21 at risk and 0 affected. These are counts for the reported categories; they should not be interpreted as proof that the procedure has no risk or that no complication occurred under any definition.
The study separately names the number of procedural complications as a secondary outcome. A result for that outcome is not reported in the registry record. The record does not give further event descriptions, event definitions, severity details beyond the serious-event category, or an account of how long participants were monitored for adverse events. Deaths are recorded as null, which means a death count is not available in the posted record; it should not be read as a reported count of zero.
In general, safety counts are more informative when event definitions, observation periods, and the population monitored are clearly described. With no comparator group, these counts cannot estimate a relative safety difference against another procedure or approach. The posted figures describe only the counts recorded for this single group.
12. What the Result Does, and Does Not, Mean
The registry record shows that a single group of 21 participants was enrolled in a study of EUS-guided Tru-Cut liver biopsy. It specifies median total specimen length, with a full range, as the primary outcome, and names procedural complications as a secondary outcome. It also posts adverse-event counts for the study group. These details allow readers to understand the design and the outcomes the study intended to assess.
The central primary result is not reported in the registry record. Without the median specimen length and its range, it is not possible to say what tissue lengths were observed, how much they varied, or whether lengths differed among the biopsy indications. The record also lacks a reported result for procedural complications. These gaps do not mean that measurements or analyses were zero; they mean the relevant results are unavailable in the registry record.
The design does not compare this procedure with another method, because it has one group and no comparator. It therefore cannot establish a comparative advantage, disadvantage, or effect. It also cannot show that specimen length predicts diagnostic adequacy, because the record does not report an adequacy threshold or the relationship between length and diagnostic findings.
The serious and other adverse-event counts are both posted as 0 affected among 21 at risk. Those counts describe the recorded events, but cannot establish absence of all complications or quantify comparative safety. The death entry is null, not a reported zero count.
In general, a study’s interpretation depends on its design, the outcomes actually reported, and their uncertainty. Here, the record gives useful design and outcome definitions but does not report the primary endpoint values or a statistical analysis. Conclusions about specimen yield, diagnostic performance, or comparative safety are therefore not supported by the posted results.
13. Why This Trial Matters Statistically
This study is statistically instructive because it separates an outcome’s definition from its result. The registry identifies median total specimen length and specifies a full range, along with indication-based groupings. That is enough to understand what was intended to be measured, but not enough to describe what happened: the endpoint values are not reported in the registry record.
Its single-group structure is also important. A one-group study can describe measurements and events in participants who underwent a procedure, but it does not provide a concurrent comparison. In general, without a comparator, observed outcomes cannot establish how they differ from outcomes under another procedure or approach. This distinction prevents descriptive findings from being mistaken for comparative evidence.
The study illustrates why endpoint choice matters. Specimen length is a procedural measure that may be relevant to tissue acquisition, but it is not itself a direct report of diagnostic adequacy or clinical benefit. General statistical interpretation requires connecting the measured endpoint to the question it is meant to address. The registry does not provide that link through histological results, adequacy criteria, or diagnostic performance measures.
Finally, the safety counts show why event reporting needs context. A count of zero in a monitored group is not equivalent to proof of zero underlying risk, and it cannot establish comparative safety without another group. Clear event definitions, follow-up information, and complete outcome reporting would help readers assess the scope and precision of the findings. Those details are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this study is that the registry record does not report the observed primary endpoint values. It defines median total specimen length and a full range, but gives neither the total results nor values by biopsy indication. This prevents assessment of the measured tissue lengths and their variability.
The study has no comparator group and is not a randomized comparison. Its design therefore cannot estimate a comparative difference between EUS-guided Tru-Cut biopsy and another method. The enrollment of 21 also does not establish the precision of the primary outcome; no estimate or uncertainty interval is reported.
The record does not provide subgroup sizes, participant flow, detailed eligibility criteria, or the number of participants with evaluable primary outcome data. Missing-data rules and the analysis population are not reported in the registry record. The outcome description does not state how specimen length was measured or define an adequacy threshold. Histological findings and diagnostic performance are also not reported.
Although procedural complications are named as a secondary outcome, a specific result for that outcome is not reported in the registry record. The adverse-event data list 0 affected for serious events and 0 for other events among 21 at risk in each category, but event definitions, observation details, and further safety descriptions are not given. The death entry is null.
A detailed statistical analysis plan, sample-size justification, and interim analysis plan are not reported in the registry record. The planning assumptions associated with sample-size illustrations do not substitute for a trial-specific design rationale or an observed treatment effect. Together, these reporting gaps limit assessment of the study’s outcomes and precision.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.) — NCT00586313.
- Registry record last updated 2016-10-17; status last verified 2016-08.
- Results first posted 2015-11-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed, single-group study of EUS-guided Tru-Cut liver biopsy with an enrollment of 21. Masking is listed as none, and no comparator group is reported. The primary outcome is median total specimen length in millimetres, with a full range, grouped by biopsy indication and for the total group. The named secondary outcome is the number of procedural complications.
The registry record does not report the primary outcome values, a result for the named secondary outcome, or a statistical analysis. It lists 0 serious adverse events among 21 at risk and 0 other adverse events among 21 at risk. The death count is null. Missing-data methods, analysis population, and detailed statistical plan are not reported in the registry record. The available record therefore describes the study and its intended measurements, but does not provide the primary results needed to evaluate specimen length.